Gender specific pharmaceuticals

ABSTRACT

The present disclosure provides a system of gender specific pharmaceuticals. The system includes a first package of a pharmaceutical for use by a male and a second package of a pharmaceutical for use by a female. The first package includes a pharmaceutical for use by a male and a first label coupled to the first package, wherein at least one of the first package and first label includes a male specifier and a recommended male dosage. The second package includes a pharmaceutical for use by a female and a second label coupled to the second package, wherein at least one of the second package and second label includes a female specifier and a recommended female dosage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/376,626, filed Apr. 5, 2019, which is a continuation of U.S.application Ser. No. 15/597,631, filed May 17, 2017, which is a divisionof U.S. application Ser. No. 15/003,243, filed Jan. 21, 2016, nowabandoned, which is a continuation of U.S. application Ser. No.11/454,109, filed Jun. 15, 2006, now U.S. Pat. No. 9,301,845, whichclaims the benefit of U.S. Provisional Application Nos. 60/755,804,filed Jan. 3, 2006, and 60/690,653, filed Jun. 15, 2005, the contents ofwhich are each incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to gender specific pharmaceuticals.

BACKGROUND OF THE INVENTION

Some fields of study recognize and account for differences between menand women better than others. Psychologists, for example, may choosedifferent therapeutic techniques to address certain emotional issueswith a man than with a woman. Personal trainers likewise may employdifferent physical training regimen for men than for women, and may havedifferent target goals for cardiovascular and muscular development.

Some fields of medical study may even consider gender during diagnosisof an illness or injury, but most do not identify or consider genderdifferences in treatment protocols, medical implants, drug development,drug dosage and delivery, and the like. Instead, many treatments onlyaccount for differences based on body weight, or create distinctionsonly between infants, children and adults while ignoring potentiallysignificant differences based on gender. In many instances, therefore,there has been little, if any, effort to refine medical science toaccount for differences between men and women.

One reason that medical science has not advanced to account for genderdifferences in treatment may be due in part to a widely held perceptionthat sexual dimorphism is relatively low in humans when compared toother animals, and therefore the differences often are ignored oroverlooked. Sexual dimorphism is the systematic difference in formbetween individuals of different gender in the same species. This mayinclude differences in size, color, or the presence of gender definingbody parts, such as horns or antlers. While in humans, the male andfemale forms are perceived differently, they tend to have a low level ofsexual dimorphism when compared to other species. For example, the bodymasses of both male and female humans are approximately normallydistributed.

However, despite this relative low-level sexual dimorphism when comparedto other species, there are physiological, muscular, and skeletaldifferences in men and women that are of particular relevance toimproved medical treatment. Many of these differences are present evenbetween men and women of similar height, weight, and build, butcurrently are not taken into consideration when treating a patient. Forexample, the female brain has more intercellular connections than themale brain, which may account for why women generally are likely torecover more of their speech abilities after a stroke than men, yetmedical treatment for men and women is virtually identical.Additionally, male bones tend to be larger in size, having greaterlengths, thicknesses, and densities. Similarly, the joints in male andfemale bodies differ. For example, the notch width at the end of thefemur in the knee joint tends to be wider in males than in females.Despite these differences, medical implants currently are limited tounisex designs. Further examples of differences between men and womenmay be found in metabolic rates, diurnal changes, range of motion. pHand hormonal changes, elasticity of body tissue, and susceptibility todiseases or medical conditions.

For example, males and females metabolize medications at different ratesand react differently to different types of medications. As a result ofthese differences, females may metabolize some analgesics and adjuvantdrugs at different rates than men, among them oxycodone, tramadol,fentanyl, bupivacaine, and diazepam. Similarly, males may respond morefavorably to tricyclic agents and females may get greater relief fromselective serotonin reuptake.

In spite of these differences, medical practitioners tend to treat maleand female patients with a gender-neutral approach. At best, medicinesmay be prescribed based on weight or body mass index (BMI), withouttaking into account other, potentially more significant genderdifferences. Medical implants and instruments are provided in limitedsizes (e.g., small, medium, and large), but each having similargeometric proportions, the same material construction, the same surfacetreatment, and the same therapeutic coating for men and women. In short,medical science has made little effort to account for many potentiallysignificant gender differences.

Perhaps another reason gender differences have not been incorporatedinto medical science is the additional complexity it would introduce forpatients and health professionals. It may be difficult, for example, fora doctor, nurse, or pharmacist to keep track of differentgender-specific dosage amounts, dosage rates, drug combinations, and thelike. Likewise, a couple, such as a husband and wife, where both arebeing treated for the same medical condition may become confused ifpresented with different medicines, or with different dosageinstructions (e.g. dosage amounts, dosage frequency, etc.) for medicineswith the same active ingredient. Additionally, if both patients aretaking the same brand of medication, it may be difficult to distinguisheach person's medicine from the other.

Regardless of the reason for the current state of medical science, itwould be desirable to have more sophisticated medical treatments thatbetter account for gender differences.

SUMMARY OF THE INVENTION

The present invention provides a system and method for accounting forgender specific differences in medical treatment. This is achieved firstby taking into account these differences so that a patient's therapy andtreatment is more closely tailored to them. This includes, for example,providing gender specific treatment, medical devices, medicines, and/orinstrumentation. These differences may result in different techniquesbeing provided for treating bones or joints (such as the knee, hip, orspine), differences in drug selection, drug delivery and dosage,different implant designs, and different treatment for soft tissuerepair. These and other non-limiting examples are further discussed indetail below.

In addition, the invention also may involve improved identificationsystems that help patients or health professionals avoid or reducepotential confusion that may result from the availability of genderspecific treatment options. For example, the medical treatment systemcan include a medical device identification system which differentiatesuse for male and female patients. The medical device identificationsystem includes a container adapted to receive a medical device and agender specifier. The gender specifier is used to identify the genderthe medical device is designed for. The gender specifier can beincorporated into a label, where the gender specifier can be in textform, symbolic form or color coded. For example, the gender specifiercan be in the text form “MALE” or “FEMALE.”

The gender specifier may also be an electronic device, such as an RFIDtag that is associated or packaged with the device or medicine so thatit can be readily identified and associated for use with a particulargender. This embodiment of the invention may be of particular use forsterilized products, medicines that are sealed in a container, or inother situations where it is difficult to visually confirm for which sexthe product is intended.

Alternatively, the medical treatment system may include a medicationcontainer having a gender-specific labeling system. The label system mayprovide information identifying the contents and gender-specificinstructions regarding usage of the enclosed medicine. The usageinformation may include, for example, the recommended dosage for one orboth genders. Thus, the gender specifier may be dosage information, butalso it may be in a text form, such as “FEMALE” and “MALE,” oralternatively may be in the form of a color coding or in symbolicrepresentations.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 depicts an exemplary knee joint;

FIG. 2 depicts an exemplary prosthetic knee joint;

FIG. 3 depicts an exemplary femoral component of a male prosthetic kneejoint;

FIG. 4 depicts an exemplary tibial component of a male prosthetic kneejoint;

FIG. 5 depicts an exemplary femoral component of a female prostheticknee joint;

FIG. 6 depicts an exemplary tibial component of a female prosthetic kneejoint;

FIG. 7 depicts an another exemplary femoral component of a prostheticknee joint;

FIG. 8 depicts an exemplary rotatable tibial component of a prostheticknee joint;

FIG. 9 depicts a partial cross section of the rotatable tibial componentof FIG. 8:

FIG. 10 depicts a platform of a rotatable tibial component of aprosthetic knee joint;

FIG. 11 depicts a platform of a rotatable/translatable tibial componentof a prosthetic knee joint;

FIG. 12 depicts another platform of a rotatable/translatable tibialcomponent of a prosthetic knee joint;

FIG. 13 depicts an exemplary male patella with pegs or contact pointsarranged based on the male anatomy;

FIG. 14 depicts an exemplary female patella with pegs or contact pointsarranged based on the female anatomy;

FIG. 15 depicts an exemplary bi-compartmental femoral component of amale prosthetic knee joint;

FIG. 16 depicts an exemplary bi-compartmental femoral component of afemale prosthetic knee joint;

FIG. 17 depicts a schematic diagram of a computer navigation system ofthe present invention;

FIG. 18 depicts a triangular mapping of a femur portion of a knee joint;

FIG. 19 depicts a triangular mapping of a tibia portion of a knee joint;

FIG. 20 depicts an exemplary vascular stent;

FIG. 21 depicts an exemplary female vascular stent;

FIG. 22 depicts a cross sectional view of an embodiment of the stent ofFIG. 20;

FIG. 23 depicts an exemplary medical implant including an energy sink:

FIG. 24 depicts a representative packaging material of the presentinvention;

FIG. 25 depicts a representative label affixed to the packaging materialof FIG. 24;

FIG. 26 depicts a representative medicine container of the presentinvention;

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a system and method for gender specificmedical treatment. As mentioned above, gender differences are oftenignored when determining how to treat a medical condition. It isbelieved that accounting for one or more of these differences duringtreatment may greatly improve the quality of care and degree of recoverythat a patient experiences.

One example where medical science currently applies a unisex approach isin the treatment of bones and joints. Three non-limiting examplesdiscussed below—namely treatment of the knee, hip, and spine—illustratehow the invention may be used to improve the quality of care a patientmay receive when gender differences are taken into account.

Knee replacements, for instance, are about twice as likely to beperformed on women as on men. There are gender-specific differences inthe bones and joint associated with the knee that are not currentlytaken into account in this area of medicine. For example, the femalepatella is generally thinner and narrower in superior and inferiordimensions, while in men it is generally wider in proportion.

Referring to FIG. 1, there is shown an anterior view of a knee joint 10,wherein the patella is not shown. The knee joint 10 includes a femoralportion 12 having medial and lateral condyles 14 and 16. A trochleargroove 18 is interposed between the medial and lateral condyles 14 and16, allowing for tracking of the patella along the end portion of thefemur 12 as the knee joint 10 is flexed and extended. A tibial portion20 of the knee joint 10 includes a tibial plateau 22, including medialand lateral menisci 24 and 26 disposed on the tibial plateau 22. Themedial and lateral condyles 14 and 16 abut the tibial plateau 22,engaging the medial and lateral menisci 24 and 26 allow for rotation ofthe tibia 20 with respect to the femur 12 and shock absorption betweenthe femur 12 and tibia 20. A central longitudinal axis of the femurportion 12 is aligned at an angle a with respect to a centrallongitudinal axis of the tibial portion 20.

Depending upon the degree and type of injury, a total or partial kneereplacement procedure can be performed when a knee joint 10 is damaged.A total knee replacement may involve replacing or repairing up to threebone surfaces, namely the medial and lateral condyles 14 and 16 of thefemur 12, the tibial plateau 22 of the tibia 20, and the back surface ofthe patella. Referring to FIG. 2, an exemplary prosthetic knee 28includes a femoral component 30 and a tibial component 32. The femoralcomponent 30 is configured to curve about the cut end portions of themedial and lateral condyles 14 and 16, having a trochlear groove 34therein to allow tracking of the patella about the femoral component 30as the knee joint 10 is flexed and extended. The tibial component 32includes flat platform 36 with a cushioning material 38, replacing themedial and lateral meniscus 24 and 26.

The femoral and tibial components 30 and 32 cooperate to permit normalknee-joint functioning. The femoral and tibial components 30 and 32 aredesigned similar in size and shape to average knee joints, and have arange of sizes to span the normal size ranges of the knee joints.

As previously discussed, there are many skeletal differences between menand women, including bone structure, configuration, size, length,thickness, density, and geometric proportion. The male femur, forexample, tends to be proportionally wider, has a greater thickness, anda wider trochlear groove. Additionally, because of the differencesbetween the male and female pelvic structures, the angular relationshipa, between the femur and the tibia in male and female knees isdifferent. Currently, these differences are not accounted for inprosthetic design, whereas in the present invention one or more of thesedifferences could be taken into account to provide gender-specificprosthetic design.

Thus, one aspect of the present invention is directed to a prostheticknee joint that is configured and dimensioned for gender specific use.To improve articulation for women, for instance, the prosthetic kneejoint may have a reduced bearing surface, such as being reduced by 10percent or more in comparison to a male prosthetic knee design. Thereduced bearing surface would allow greater range of motion of theimplant corresponding to the greater range of motion typically exhibitedin women. Overall, the implant for women may also be significantlythinner, such as being at least 5 percent thinner, at least 10 percentthinner, or alternatively at least 20 percent thinner than implants formen. A formal prosthetic knee for women may also have one or more of thefollowing: thinner runners to help improve range of motion, lesseramount of metal, or greater flexibility.

If the female implant is significantly thinner or has a much smallersurface area contacting bone than a male implant, it may be desirable toprovide more ingrowth surface on the female implant in order to enhancefixation. Fixation can also be increased by using a different amount orconfiguration of bone cement, the grouting material frequently used forfixation of a prosthetic component. In this regard, the presentinvention also contemplates female specific and male specific bonecement, with the composition of the female bone cement differing fromthe male bone cement. For example, fillers could be added to the PMMA(the principal component of the bone cement) to change the mechanicalproperties. Additionally, other components (such as an antibiotic) canbe selected depending on whether the intended recipient is a male or afemale. In this regard, a female bone cement may have added componentsto address the osteoporotic bone found in women. Such components includecalcium supplements and other agents for promoting an osteogenic orosteoconductive effect (or slowing the process of bonedemineralization).

Referring to FIG. 3, a male femoral component 40 of a knee joint implantof the present invention is provided. The femoral component 40 includesmedial and lateral condyle portions 42 and 44 each having a width W₁ anda radius R₁. A trochlear groove 46 is disposed between the medial andlateral condyle portions 42 and 44 and has a width W2. The widths W1 andW2 and the radius R1 of the femoral components 40 are provided in arange of sizes to span the normal size ranges of male human knee joints.Additionally, the thickness t₁ and the material densities of the femoralcomponents 40 are selected to correspond to male bone thickness anddensities.

Referring to FIG. 4, a male tibial component 48 of a knee joint of thepresent invention is provided. The tibial component 48 includes flatplatform 50, having a substantially oval shape, wherein the cushioningmaterial 52 replaces the medial and lateral meniscus 24 and 26. A bonespike 54 is included for insertion into the prepared end of the tibia,securing the tibial component 48 to the tibia. The bone spike 54 can besubstantially conical in shape, having a maximum diameter d₁ and lengthl₁.

Referring to FIG. 5, a female femoral component 60 of a knee jointimplant of the present invention is provided. The femoral component 60includes medial and lateral condyle portions 62 and 64 each having awidth W₃ and a radius R₂. A trochlear groove 66 is disposed between themedial and lateral condyle portions 62 and 64 and has a width W₄. Thewidths W₃ and W₄ and the radius R₂ of the femoral components 60 areprovided in a range of sizes to span the normal size ranges of femalehuman knee joints. Additionally, the thickness t₂ and the materialdensities of the femoral components 60 are selected to correspond tofemale bone thickness and densities.

Referring to FIG. 6, female tibial component 70 of a knee joint of thepresent invention is provided.

The tibial component 70 includes flat platform 72, having asubstantially elongated oval shape, wherein the cushioning material 74replaces the medial and lateral meniscus 24 and 26. A bone spike 76 isincluded for insertion into the prepared end of the tibia, securing thetibial component 70 to the tibia. The bone spike 74 can be substantiallyconical in shape, having a maximum diameter d₂ and length h.

As previously discussed, the male femoral component 40 will generallyhave greater widths W₁ and W₂ and the radius R₁, thus bearing surfacearea, than that of comparable female femoral component 60 widths W₃ andW₄ and the radius R₂. Similarly, the male femoral component 40 willgenerally have a greater material thickness t₁ than that of thickness t₂of a comparable female femoral component 60. Thus, a “large” size for amale prosthetic knee joint may differ significantly in size, proportion,and construction from a large-sized prosthetic knee joint for women.Furthermore, as shown in FIG. 5, an upper section 68 of the femalefemoral component 60 can be generally narrower than that of a comparablymale femoral component 40, to accommodate structural differences betweenthe female and male femurs. In other words the female femoral component60 design can have scalloped edges compared to the male femoralcomponent 40 design. Additionally, the thickness, the materialdensities, and the material composition of the femoral components 40 and60 may be selected to correspond to different male and female bonethickness and densities. Additional dimensions of the femoral portion ofthe knee joint can be utilized in the design and configuration of thefemoral components 40 and 60.

Similar to the femoral components 40 and 60, the tibial components 58and 70 are designed and configured for use in replacement of the kneejoint in males and females. The dimensions of the tibial components onceagain may be provided in a range of sizes to span the normal size rangesof male and female human knee joints. As shown in FIGS. 4 and 6, themale platform 50 has a substantially oval shape, whereas the femaleplatform 72 has an elongated oval shape. The shapes of the platforms 50and 72 are selected to accommodate the differences in sizes and bearingsurface areas of the corresponding male and female femoral components 48and 60. Additionally, the thickness and the material densities of thetibial components are selected to correspond to or function with maleand female bone thickness, densities, geometry, range of motion, or thelike. Furthermore, additional dimensions of the tibial portion of theknee joint can be utilized in the design and configuration of the tibialcomponents 48 and 70.

Thus, a gender-specific design may be identified by one component havingless material than for the opposite sex. Furthermore, additionaldimensions of the femoral portion of the knee joint can be utilized inthe design and configuration of the femoral components. One or more ofthese dimensions may be varied so that an implant is more suited to amale or female patient. Thus, an implant design may be consideredgender-specific if one or more of these parameters has been selected tobetter match either a male or female.

A gender-specific prosthetic design may also be identified by comparingrelative differences that exist between a female design and a maledesign. For example, if one or more dimensions (e.g., bearing surfacearea, widths, radii, curvature, thickness of material, amount of metal,range of motion, flexibility, etc.) or relative proportions (e.g.,relative width or relative differences in angles, minimum or maximumsizes, etc.) or an implant design for one sex varies by more than 5percent, or alternatively by 10 percent or more, or even by about 20percent or more, from an implant designed for the opposite sex, then thedesign may qualify as being gender-specific.

Referring to FIG. 7, another femoral component 80 of a knee jointimplant of the present invention is provided. The femoral component 80includes medial and lateral condyle portions 82 and 84. The medialcondyle portion 82 has a width Wm and a radius R_(m) and the lateralcondyle portion 84 has a width W_(L) and a radius R_(L), wherein thewidth W_(m) and W_(L) can be of equal dimension, or in the alternative,the widths W_(m) and W_(L) can be of non-equal dimension. Similarly, themedial and lateral condyle portions 82 and 84 radii R_(m) and R_(L) canbe of equal dimension, or in the alternative, radii R_(m) and R_(L) canbe of non-equal dimension. In this regard, the size differences betweenthe widths and/or radii of the medial and lateral condyle portions canbe at least 5 percent, 10 percent, or 20 percent. A trochlear groove 86is disposed between the medial and lateral condyle portions 82 and 84and has a width W₁.

In this manner, the widths W_(m) and W_(L) and the radii R_(m) and R_(L)of the femoral components 80 can be provided in a range of sizes to moreprecisely emulate the size and dimensions of a male or female human kneejoints. For example, the radii R_(m) and R_(L) of the medial and lateralportions 82 and 84 of the femoral component 80 can be selected such thatthe radius Rm of the medial condyle portion is larger with respect tothe radius R_(L) of the lateral condyle portion. As such, the radiiR_(m) and R_(L) of the medial and lateral portions 82 and 84 form asubstantially partial conical surface. Additionally, the thickness 3 andthe material densities of the femoral components 80 are selected tocorrespond to male or female bone thickness and densities.

As previously discussed, a male femoral component will generally havegreater widths W_(m) and W_(L) and the radii R_(m) and R_(L), thusbearing surface areas, than that of a comparable female femoralcomponent widths W_(m) and W_(L) and the radii R_(m) and R_(L).Similarly, the male femoral component will generally have a greatermaterial thickness t3 than that of thickness of a comparable femalefemoral component. Thus, a “large” size for a male prosthetic knee jointmay differ significantly in size, proportion, and construction from alarge-sized prosthetic knee joint for women. Furthermore, as shown inFIG. 5, an upper section of the female femoral component can begenerally narrower than that of a comparably sized male femoralcomponent to accommodate structural differences between the female andmale femurs. In other words a female femoral component design can havescalloped edges compared to the male femoral component design.Additionally, the thickness, the material densities, and the materialcomposition of the femoral components may be selected to correspond todifferent male and female bone thickness and densities. Additionaldimensions of the femoral portion of the knee joint can be utilized inthe design and configuration of the femoral components.

Referring to FIG. 8, a tibial component 90 of a knee joint of thepresent invention is provided. The tibial component 90 includes aplatform 92, having a substantially oval shape, wherein a cushioningmaterial 94 replaces the medial and lateral meniscus 24 and 26. A bonespike 96 is included for insertion into the prepared end of the tibia,securing the tibial component 90 to the tibia. The bone spike 96 can besubstantially conical in shape, having a maximum diameter d₁ and lengthl₁. The platform 92 can be rotatably connected to the bone spike 96,such that the platform 92 can rotated with respect to the centrallongitudinal axis “A” of the bone spike 96.

In an embodiment as shown in FIG. 9, the platform 92 includes a slottedsection 98, in which a head portion 100 of the bone spike 96 ispositioned. The slotted section 98 is configured to capture the headportion 100 of the bone spike 96, securing the head portion 100 withinthe slotted section 98, yet allowing the platform 92 to rotate withrespect with the bone spike 96. In this manner, the platform 92 canrotate with respect to a femoral component as the knee joint is movedbetween flexion and extension, thereby decreasing the frictional forcesbetween the contacting surfaces of the femoral component and acushioning material of the platform 92. Furthermore, the rotation of theplatform 92 can decrease the stresses provided on the implant/boneinterface, decreasing the likelihood of failure and increasing the lifeexpectancy of the implant. It is contemplated that the other rotational,translation, and positional configurations of the platform 92 withrespect to the bone spike 96 can be provided to further increase theefficiency of emulating a natural knee joint and accounting for theanatomical differences between male and female joints.

Referring to FIG. 10, the bone spike 96 can be centrally positioned onthe flat platform 92, such that the center 102 of the platform 92 isaligned along the central longitudinal axis of the bone spike 96.Alternatively, the bone spike 96′ can be positioned offset from thecenter 102 of the platform 92, such that the center 102 of the platform92 is rotatable about the bone spike 96′.

Referring to FIG. 11, the platform 92 can include an elongated slottedsection 104, such that the platform 92 can slide in the anterior andposterior directions as the knee joint is moved between flexion andextension. In addition, the platform 92 can rotate with respect to thebone spike 96 as the knee joint is moved between flexion and extension.In this manner, the compound movement for the platform 92 can be used toemulate high flexion.

Referring to FIG. 12, the platform 92 includes an angular elongatedslotted section 106, such that the platform 92 can slide substantiallyin the anterior/posterior and medial/lateral directions as the kneejoint is moved between flexion and extension. In addition, the platform92 can rotate with respect to the bone spike 96 as the knee joint ismoved between flexion and extension.

Similar to the femoral components, the tibial components 90 are designedand configured for use in replacement of the knee joint in males andfemales. The dimensions of the tibial components once again may beprovided in a range of sizes to span the normal size ranges of male andfemale human knee joints. As showing in FIGS. 4 and 6, the male platform50 has a substantially oval shape, whereas the female platform 72 has anelongated oval shape. The shapes of the platforms 50 and 72 are selectedto accommodate the differences in sizes and bearing surface areas of thecorresponding male and female femoral components 48 and 60.Additionally, the thickness and the material densities of the tibialcomponents are selected to correspond to or function with male andfemale bone thickness, densities, geometry, range of motion, or thelike. Furthermore, additional dimensions of the tibial portion of theknee joint can be utilized in the design and configuration of the tibialcomponent 90.

Referring to FIGS. 13 and 14, a male patella 110 and a female patella112 are provided. As shown in these figures, the male and femalepatellas 110 and 112 have substantially different shapes, where thefemale patella 112 is more elongated with respect to the male patella110. As such, when replacement patellas are provided, they are providedin accordance with the gender of the patient.

Furthermore, in surgical procedures requiring resurfacing of the patellasurfaces, contact pegs 114 can be affixed to the surface, providingmultiple point contact surfaces between the patella and the femur orfemoral implant. As male and female patellas 110 and 112 have differentshapes, the arrangement of the pegs 114 can be changed accordingly. Asshown in FIG. 13, the pegs 114 are positioned in a substantiallytriangular configuration for the male patella, allowing for the widersurface of the male patella 110. As shown in FIG. 14, the pegs 114 arepositioned in a substantially linear configuration, allowing for themore linear surface of the female patella 114. Providing such contactpegs (rather than replacing or resurfacing the entire patella) offers anumber of advantages, which include greater applicability to minimallyinvasive procedures, reduced articulating surface area, etc. PublishedU.S. Patent Application Publication No. US 2003/0028196 A1 discloses anumber of such pegs or reduced bearing surface implants that can be usedwith the present invention. The entire content of this patentapplication is incorporated herein by reference.

Although FIGS. 2-14, show total knee replacement components, the presentinvention is well-suited for partial knee replacement components such asuni-compartmental and bi-compartmental implants. The present inventionalso contemplates the use for re-surfacing and surface bearingprocedures and/or components.

Referring to FIG. 15, a bi-compartmental male femoral component 120 of aknee joint implant of the present invention is provided. The femoralcomponent 120 includes medial and lateral components 122 and 124. Themedial component 122 includes a medial condyle portion 126 having awidth W_(m) and a radius R_(m). The lateral component 124 includes alateral condyle portion 128 having a width W_(L) and a radius R_(L). Aspreviously discussed, the widths W_(m) and W_(L) can be of equaldimension or can be of different dimensions. Similarly, the medial andlateral condyle portions 126 and 128 radii R_(m) and R_(L) can be ofequal dimension or can be of non-equal dimension. A trochlear groove 130formed by the combination of the medial and lateral components 122 and124 is disposed between the medial and lateral condyle portions 126 and128 and has a width W₁.

Referring to FIG. 16, a bi-compartmental female femoral component 140 ofa knee joint implant of the present invention is provided. The femoralcomponent 140 includes medial and lateral components 142 and 144. Themedial component 142 includes a medial condyle portion 146 having awidth Wm and a radius R_(m). The lateral component 144 includes alateral condyle portion 148 having a width W_(L) and a radius R_(L). Aspreviously discussed, the widths W_(m) and W_(L) can be of equaldimension or can be of different dimensions. Similarly, the medial andlateral condyle portions 146 and 148 radii R_(m) and R_(L) can be ofequal dimension or can be of different dimensions. A trochlear groove150 formed by the combination of the medial and lateral components 142and 144 is disposed between the medial and lateral condyle portions 146and 148 and has a width W₁. The widths W_(m) and W_(L) and the radiiR_(m) and R_(L) of the medial and lateral components 132 and 134 areprovided in a range of sizes to span the normal size ranges of femalehuman knee joints. Additionally, the thickness t2 and the materialdensities of the medial and lateral components 132 and 134 are selectedto correspond to female bone thickness and densities.

As previously discussed, male femoral components will generally havegreater widths W_(m) and W_(L) and radii R_(m) and R_(L), thus bearingsurface area, than that of comparable female femoral components widthsW_(m) and W_(L) and radii R_(m) and R_(L). Similarly, the male femoralcomponents will generally have a greater material thickness t₁ than thatof thickness of a comparable female femoral component. Thus, a “large”size for a male prosthetic knee joint may differ significantly in size,proportion, and construction from a large-sized prosthetic knee jointfor women. Furthermore, as shown in FIGS. 15 and 16, an upper section152 of the female femoral components 142 and 144 can be generallynarrower than that of a comparably male femoral components 122 and 124,to accommodate structural differences between the female and malefemurs. In other words, the upper section 152 is such that the femalefemoral components 142 and 144 have scalloped edges compared to the malefemoral components 122 and 124. Additionally, the thickness, thematerial densities, and the material composition of the femoralcomponents 122, 124, 142, and 144 may be selected to correspond todifferent male and female bone thickness and densities. Additionaldimensions of the femoral portion of the knee joint can be utilized inthe design and configuration of the femoral components 142 and 144.

Thus, a gender-specific design may be identified by one component havingless material than for the opposite sex. Furthermore, additionaldimensions of the femoral portion of the knee joint can be utilized inthe design and configuration of the femoral components. One or more ofthese dimensions may be varied so that an implant is better suited to amale or female patient. Thus, an implant design may be consideredgender-specific if one or more of these parameters has been selected tobetter match either a male or female.

A gender-specific prosthetic design may also be identified by comparingrelative differences that exist between a female design and a maledesign. For example, if one or more dimensions (e.g., bearing surfacearea, widths, radii, curvature, thickness of material, amount of metal,range of motion, flexibility, etc.) or relative proportions (e.g.,relative width or relative differences in angles, minimum or maximumsizes, etc.) or an implant design for one sex varies by more than 5percent, or alternatively by 10 percent or more, or even by about 20percent or more, from an implant designed for the opposite sex, then thedesign may qualify as being gender-specific.

Referring to FIG. 17, a computer navigation system 160 of the presentinvention is provided and schematically shown. The computer navigationsystem 160 includes a central processing unit (CPU) 162, having aprocessor 164 and memory 166, a display device 168, and input devices,including a keyboard 170 and a stylus 172. A computer program is storedon the CPU 162, where the computer program can be used to aid in theselection, preparation, and insertion of implants into a patient. Thestylus 172 can be used to provide single point locations or multiplepoint locations to outline the contours of a surface of a portion of ajoint. The navigation system 160 can further include a printer 174.

An anatomical database is stored on the CPU 162 and is accessible by thecomputer program to determine appropriate implants for use in thepatient. In an embodiment, the anatomical database includes informationrelating to a joint in the body of a patient, for example a knee joint.The anatomical database includes a library of joint mappings, having abroad range of joint sizes, as well as including information relating togender differences in the joints. For example, the anatomical databasecan include information on bone thickness, density, the radii of themedial and lateral condyles, the widths of the medial and lateralcondyles, the width of the trochlear groove, and the angularrelationship of the medial and lateral condyles with respect to thecentral longitudinal axis of the femur for a broad range of differentsize joints for male and females. In other words, conventional computernavigation systems include a library or database of anatomicalparameters that are used in the registration or other calibratingprocess, but the anatomical parameters are based on a unisex model thatrepresents a composite of male and female anatomies. In contrast, thecomputer navigation system of the present invention includes a malelibrary or database and a female library or database. The separatelibraries or databases include differences in the anatomy. Exemplarydifferences have been discussed previously and additional genderdifferences are described below. Thus, with the computer navigationsystem of the present invention, the patient's gender is selected andthe appropriate library or database is used in the registration or othercalibrating process.

In a method of use, the stylus 172 is used to the map the joint, with atleast three points located on the joint to determine the anatomicalparameters of the joint. The joint mapping is displayed on the displaydevice 168. Referring to FIG. 18, in a knee joint 10 the stylus 172 mapsthe femoral portion 12 of the knee joint 10. The stylus 172 is used tolocate a home point “HP” on the femur 12, where the home point lies onthe top surface on the femur 10 in a plane defined by the centrallongitudinal axis “A” of the femur 10. At least two additional points“P₁” and “P₂” are located with respect to the home point, such as endsurfaces of the medial and lateral condyles 14 and 16. The three points(HP, P₁ and P₂) define a triangular mapping “T₁” of the femoral portion12 of the knee joint 10, which is displayed on the display device 168.In addition to the triangular mapping, gender information is alsoprovided.

In an alternative embodiment, the display device 168 displays a genericknee joint, highlighting a point on the joint to be located using thestylus 172. For example, a home point “HP” and the end surfaces of themedial and lateral condyles are highlighted on the generic knee joint.The stylus 172 is utilized to locate the corresponding points on theknee joint 10 of the patient.

The computer program utilizes the mapped points and the genderinformation to provide a preliminary model for the femoral portion 12,which is displayed on the display device 168. The preliminary model isbased on a statistical analyzing of the relationship of the mappedpoints and the gender information, in comparison to the knee jointdatabase. The resulting preliminary model can include information on theradii of the medial and lateral condyles, the widths of the medial andlateral condyles, the width of the trochlear groove, and the angularrelationship of the medial and lateral condyles with respect to thecentral longitudinal axis of the femur. Based on the preliminary modelan appropriately size femoral implant can be selected for use, as wellas a corresponding cutting pattern for that implant.

The above system has been described as using three points to provide atriangular mapping. However, it is understood that additionalinformation can be utilized to provide a more refined model of thefemoral portion 12 of the knee joint 10. For examples, the input device170 can be used to map anterior and posterior points of the medial andlateral condyles, the femoral contacting surface of the medial andlateral condyles, the trochlear groove, etc. Additional information,such as the bone diameter and angular relationship between the femur andthe pelvis can be utilized to refine the model.

Referring to FIG. 19, in a similar method, the computer navigationsystem 160 can be used to map the tibial portion 20 of the knee joint10. The stylus 172 is used to locate reference points on the end portionof the tibia 20 with respect to the home point “HP” on the femur 12. Forexample, the stylus 172 can be used to map points along the tibialplateau 22, including the tibial plateau end points P₃ and P₄, toproviding a triangular model “T₂” of the tibia 20 as well as the angularrelationship “a” between the tibia 20 and femur 12.

The computer program utilizes the mapped points and the genderinformation to provide a preliminary model for the tibial portion 20,which is displayed on the display device 168. The tibial portion 20 canbe displayed either individually or in relation to the femoral portion12. The resulting preliminary model can be used to select anappropriately sized tibial implant, as well as a corresponding cuttingpattern for that implant. The selection of the femoral and tibialimplants is not only based on the inputted data, by also on the implantsthemselves, and their ability to function appropriately together.

Other gender-specific differences may be used to further customize amedical implant such as a prosthetic knee for men or women. Forinstance, surfaces of the device may have different ingrowth surfaces,porosity. HA, or BMP coated or bonded to it.

In addition to the knee joint, additional prosthetic implants can bedesigned and configured for gender specific use. For example, as notedabove, the female pelvis is distinguished from that of the male by itsbones being more delicate and shallower in depth. The ilia of the femalepelvis are less sloped, and the anterior iliac spines more widelyseparated; hence the greater lateral prominence of the hips in females.The superior aperture of the lesser pelvis is larger in the female thanin the male; it is more nearly circular, and its obliquity is greater.The inferior aperture is larger and the coccyx more movable. The sciaticnotches are wider and shallower, and the spines of the ischia projectless inward. The ischial tuberosities and the acetabula are wider apart,and the former are more everted. The pubic symphysis is less deep, andthe pubic arch is wider and more rounded than in the male, where it isan angle rather than an arch.

Because of the differences between the male pelvis and the femalepelvis, hip configuration and alignment differ between the genders. Suchdifferences require differing implant configurations. In accordance withthe present invention, prosthetic hip implants may be designed andconfigured for gender specific use, taking into account the structuraldifferences between the female and male pelvis and connecting femurs.

Thus, another example of where the present invention may be used toimprove currently available implant designs is in treatment of injuriesto the pelvis or hip. As mentioned above, an implant designed for womenmay be designed to provide greater range of motion than a similarimplant designed for men. Females often benefit from having a greaterrange of motion for hips just as they do for knees. Thus, the femaledesign may be more flexible in the acetabular component, more flexiblein the femoral stem, or have a greater modulus of elasticity (especiallyin more osteoporotic bone). Designing the female prosthetic so that thefemoral head contacts a thinner acetabulum also may change range ofmotion and stability to be more suitable for women than men.

Additionally, the offset for the femoral head and neck region may bedifferent for men than women. For example, a female design may have lessoffset while a male design may have a greater offset to increase thelever arm. The difference in offset may be about 5 percent or greater inone embodiment, although as described above the offset may differ by 10percent or more, or by 20 percent or more.

Another way in which prosthetic designs such as the hip may incorporategender-specific features is with the use of different ingrowth surfaces.For example, the superior portion under compression on the acetabularcomponent may have HA coating and/or a roughened surface texture for onegender while less or no HA coating and/or a smoother surface texture forthe opposite gender. Likewise, the inferior coating may be porous orfiber metal coating or porous tantalum coating so that there would betwo or more ingrowth surfaces on the same gender-specific implant.

Since it may be difficult to immediately recognize some of thesegender-specific design differences, one or more components may becolor-coded so that they may be more readily identified by visualinspection. For example, the rotating or bearing surface of the femoralhead may have one color for women and another color for men. Thus, acomponent having a pink visible surface may signify that thegender-specific design of the implant is for women, while a blacksurface may signify that the gender-specific design is for men. Thiscolor-coding of one or more components may be used in place of or inconjunction with any other gender identification systems, includingthose described elsewhere herein.

It is further contemplated the gender specific prosthetic implants canbe designed and configured for use in the any joint in a body, includingankle, knee, hip, spine, neck, wrist, elbow, and shoulder. In spinetreatment, for example, a nucleus pulposes implant for women may havegreater elasticity or greater hydrophilic capability. Likewise forspinal implants, the shape, angle, or distance distracted between thedisc space may be designed to be gender-specific for men and women. Inaddition, disc replacement technology may have gender-specific featuressuch as differences in disc height or angulation changes such aslordosis or rotational angle. Likewise, a spinal cage could havegender-specific designs that vary in thickness or forced expansion.

Bone cement, such as used in spine treatment or in treating other bonesin the body, also may have a different viscosity for men and women,different rates of introduction into the body, or different amounts ofbonding or interdigitation, especially with osteoporotic bone in femalesversus males.

The use of gender-specific designs also may result in kits of implants,tools and devices tailored primarily for a particular gender. Forinstance, a kit of implants of varying sizes intended for women may havea generally smaller size than a kit of similar implants intended formen. Providing a gender-specific kit allows for the reduction orelimination of conventional kit components that might primarily beintended for use on the opposite sex. Likewise, there may be differencesin the tools and instruments provided in one kit versus another due toanatomical, physiological, or other differences between men and women.One benefit of providing gender-specific kits is that it may reduce theamount of variety of devices and instruments that may be prepared for aparticular surgery. The potential reduction in complexity and number ofdevices and instrumentation may in turn allow a physician to performsurgeries more efficiently and successfully.

Sutures also may be designed to have gender-specific features. Today,suture materials are all designed to have the same properties for menand women. Under the present invention, however, suture material mayhave greater elasticity for females than for males.

Stents are another example where a currently unisex approach could beimproved by taking into account gender-specific differences. Stents areused in a wide variety of applications, such as for aneurysms, aortic,cardiac, carotid, vascular anastomosis, vascular angioplasty, and thelike. As is well known stents are typically inserted in a compressedstate and then expanded when in position. The expansion of stents todayis the same for men and women; yet female vessel tissue tends to be moreelastic than in men. Therefore, it is believed the vessels in womenwould apply a less resistance to an opening stent than in men. Whilethis difference is not currently taken into account, one embodiment ofthe present invention would be to design a stent to require a loweropening force for women than a stent designed for men. For example, aballoon used to expand a male designed stent may apply a greater openingforce than a balloon used to expand a female designed stent.

Furthermore, stent expansion may involve less elasticity and greaterstiffness in men than in women since male vessel tissue is generallymore rigid than for women. Since female tissue often is more pliable, afemale stent design may have a lower modulus of elasticity to expand,may be more elastic, and less rigid. In addition, a male stent designmay have differences in drug release than in women. For example, a malestent design may have a greater drug release associated with it, mayhave specific localized drug release, or a greater concentration of drugreleased over a shorter period. Additionally, different drugcombinations may be associated with a male stent design than for afemale stent design. The stent may have multiple layers for providingdifferent drug deliveries for men and women. For example, one layer maybe porous or permeable that allows a drug to be released from an innercoating or layer. The porous or permeable coating or layer may havedifferent apertures for men than for women, thereby providing agender-specific drug delivery. In addition, the coatings or layers mayreact differently to temperature, pH, or other differences in theintended environment that may be present between men and women. Forexample, a porous or permeable layer may have an outer coating thatdissolves when deployed in a female, thereby allowing the inner coatingor layer to be released into the body, but remains substantially intactduring exposure in a male body. Alternatively, the outer coating mayhave a different rate of degradation for men than women, therebyallowing for gender-specific rates of drug delivery.

FIG. 20 illustrates an embodiment of the invention concerning anarterial stent 180. Stents are particularly useful in the treatment andrepair of blood vessels after a stenosis has been compressed bypercutaneous transluminal coronary angioplasty (PTCA), percutaneoustransluminal angioplasty (PTA), or removed by atherectomy or othermeans, to help improve the results of the procedure and reduce thepossibility of restenosis. Stents also can be used to provide primarycompression to a stenosis in cases in which no initial PTCA or PTAprocedure is performed. While stents are most often used in theprocedures mentioned above, they also can be implanted on another bodylumen such as the carotid arteries, peripheral vessels, urethra,esophagus and bile duct.

In typical PTCA procedures, a guiding catheter or sheath ispercutaneously introduced into the cardiovascular system of a patientthrough the femoral arteries and advanced through the vasculature untilthe distal end of the guiding catheter is in the aorta. A guidewire anda dilatation catheter having a balloon on the distal end are introducedthrough the guiding catheter with the dilatation catheter sliding overthe guidewire. The guidewire is first advanced out of the guidingcatheter into the patient's vasculature and is directed across thearterial lesion. The dilatation catheter is subsequently advanced overthe previously advanced guidewire until the dilatation balloon isproperly positioned across the arterial lesion. Once in position acrossthe lesion, the expandable balloon is inflated to a predetermined size,such as with a radiopaque liquid, at relatively high pressure todisplace the atherosclerotic plaque of the lesion against the inside ofthe artery wall and thereby dilate the lumen of the artery. The balloonis then deflated to a small profile so that the dilatation catheter canbe withdrawn from the patient's vasculature and the blood flow resumedthrough the dilated artery. As should be appreciated by those skilled inthe art, while the above-described procedure is typical, it is not theonly method used in angioplasty.

In angioplasty procedures of the kind referenced above, abrupt reclosuremay occur or restenosis of the artery may develop over time, which mayrequire another angioplasty procedure, a surgical bypass operation, orsome other method of repairing or strengthening the area. To reduce thelikelihood of the occurrence of abrupt reclosure and to strengthen thearea, a physician can implant an intravascular prosthesis formaintaining vascular patency, commonly known as a stent, inside theartery across the lesion. Stents are generally cylindrically shapeddevices which function to hold open and sometimes expand a segment of ablood vessel or other arterial lumen, such as a coronary artery. Stentsare delivered in a radially compressed condition to the target locationand then are deployed into an expanded condition to support the vesseland help maintain it in an open position. In one embodiment, the stentmay be a self-expanding type formed from, for example, shape memorymetals or super-elastic nickel-titanium (NiTi) alloys, which willautomatically expand from a compressed state when the stent is advancedout of the distal end of the delivery catheter into the body lumen.

Physiological differences between the female and male genders may alsobe found in the cardiovascular systems of men and women. For example,women, on average, have smaller diameter and thinner-walled arteriesthan men. The invention accounts for these physiological differences byproviding different stent designs for men and women. Thus, the inventionprovides stents 180 that are configured and dimensioned for genderspecific use. As noted above, upon insertion into an artery, the stent180 expands from an initial, compact condition to an expanded conditionhaving a diameter D₁, wherein the rate of expansion E is dependent onthe material properties of the stent 180. In the expanded condition, thediameter D₁ is of sufficient size to impart an expansive force Fe ontothe inner arterial wall.

In a first embodiment, the stent 180 is designed and configured for usein angioplasty procedures in males. One or more stents 180 may beprovided having at least one rate of expansion E and at least oneexpanded diameter D₁ configured and dimensioned to span the normal sizeranges of male human arteries. Additionally, the expansive force Feimparted onto the inner arterial wall is a function of the arterial wallthickness, such that the expansive force Fe is of sufficient strength tomaintain the artery in an open condition preventing reclosure, withoutdamage to the inner arterial wall. Furthermore, additional dimensions ofthe arteries can be utilized in the design and configuration of thestent 180.

In a second embodiment, shown in FIG. 21, the stent 182 is designed andconfigured for use in angioplasty procedures in females. Once again, oneor more stents 182 may be provided having at least one rate of expansionE and at least one expanded diameter D2 configured and dimensioned tospan the normal size ranges of female human arteries. Additionally, theexpansive force Fe imparted onto the inner arterial wall is a functionof the arterial wall thickness, such that the expansive force is ofsufficient strength to maintain the artery in an open conditionpreventing reclosure, without damage to the inner arterial wall.Furthermore, additional dimensions, gender-specific features, or otherparameters of the arteries can be utilized in the designed andconfiguration of the gender specific stent 182. For instance, the stent82 also may account for the effect of an illness or medical condition onthe strength, size, or thickness of a vessel or vessel wall, whichoptionally may also be dependent at least in part upon gender. Some ofthe structural features of the stents that account for gender-specificdifferences include the following: stent 182 has ends that flareoutwardly, while stent 80 is substantially cylindrical; stent 182 hasfewer openings than stent 180; and the openings in the sidewall of stent182 are generally larger than the openings in the sidewall of stent 180.

As discussed above, coatings can be used to make stent designs genderspecific. It is well known that the stents 180 and 182 can be coatedwith a pharmaceutical agent 184. As shown in FIG. 22, the pharmaceuticalagent 184 can be combined with a coating 186 or other medium used forcontrolled release rates of the pharmaceutical agent 184. Thepharmaceutical agent 184 can be incorporated into or covered by amonolithic layer or coating, wherein the agent 184 diffuses through thecoating 186 and is released into the surrounding fluid. Alternatively,the coating 186 can be a degradable coating, such that as the coating186 degrades the pharmaceutical agent 184 is released.

The pharmaceutical agent 184 can be a drug used for the prevention ortreatment of restenosis. Formulations useful for restenosis preventionor treatment can include, but ar not limited to, heparin and heparinfragments, colchicine, taxol, agiotensin converting enzyme (ACE)inhibitors, angiopeptin, Cyclosporin A, goat-anti-rabbit PDGF antibody,terbinafine, trapidil, interferon-gamma, steroids, ionizing radiation,fusion toxins, antisense oligonucleotides, gene vectors, and rapamycin.

In addition to or as an alternative to, the pharmaceutical agent 184 maybe a therapeutic biologic agent. Examples of such agents include, but amnot limited to, hormones, cells, fetal cells, stem cells, bonemorphogenic proteins (BMPs), tissue inductive factors, enzymes,proteins, RNA, viruses, etc.

As previously discussed, men and women may metabolize some medicationsat different rates and react differently to different types ofmedications. Just as the size, shape, and other performancecharacteristics of a stent may be tailored or customized primarily for aparticular gender, the pharmaceutical agents used with the stents alsomay be tailored primarily for a particular gender. Thus, one embodimentof the invention provides a coated stents 180, 182 where the coating isformulated differently for different genders.

It should be noted that customizations of devices or treatmentsaccording to the invention may be used individually or in combinationwith other embodiments described herein or variations thereto. Forinstance, a single stent construction used for both men and women mayhave different coatings intended primarily for different genders. Inaddition, however, different coatings may also be used on differentstent constructions that are designed primarily for a particular gender.

In one embodiment using a pharmaceutical agent 184 coated onto the stent180, 182, the pharmaceutical agent 184 release rate and dosage areselected to correspond to expected male metabolization and reactions. Acoating 186 may also be provided on the stent 180, 182 so that thepharmaceutical agent 184 is covered by or incorporated into the coating186. The coating 186 may be used to control the timing and release rateof the pharmaceutical agent 184. For example, the pharmaceutical agent184 may be released gradually through diffusion through the coating 184or after at least partial degradation of the coating 186. In thismanner, the coating 186 can be designed and configured to release thepharmaceutical agent 184 at a rate and dosage corresponding tometabolization and potential reactions of primarily either men or women.

Similarly, the pharmaceutical agent 184 release rate and dosage may beselected to correspond to expected female metabolization and reactionsin the same manner.

While in the foregoing a stent 180, 182 was depicted, in otherembodiments, similar techniques may be used to coat other types ofimplantable medical devices, such as hip and knee replacements (totaland partial), spinal implants, scaffolds, biological implants or grafts,tissue grafts, screws, plates, rods, prosthetic devices, etc.

A gender-specific design may also involve altering or controlling thetreated area differently for men than for women. Referring to FIG. 23 amedical implant in the form of a prosthetic knee joint 190, including afemoral and tibial component 192 and 194, is provided. The femoralcomponent 192 is configured to provide a localized environmental changein a body of a patient. A localized increase in temperature can havebeneficial effects, which include (but are not limited to): aiding inthe alleviation of localized pain, fighting of local infections, andincreasing vascular flow and permeability of vessels at the treatmentsite to control delivery of pharmaceutical agent. For example, alocalized increasing in temperature increases the permeability of thelocal tissue, allowing for an increased and more efficient absorption ofthe pharmaceutical agent into the treatment site.

The femoral component 192 includes an energy sink 196, wherein theenergy sink 196 can be used to control the localized temperature of thesurrounding tissue. For example, the energy sink 196 can be a heat sink,wherein the heat sink 196 is charged by an internal or external energyunit 198. The heat sink 196 produces a local increase in temperature.

The male and female genders react differently to localized changes intemperatures. For example, a localized increase in temperature of Bdegrees may have beneficial effect on a female, but no effect on a male.As a result of the differing effects on the male and the female genders,the applied energy is gender dependent. For example, in a female Xamount of energy may be required to heat the heat sink 196 tosufficiently raise the localize temperature to have a beneficial effect.In contrast, in a male, Y amount of energy may be required to heat theheat sink 196 to sufficiently raise the localize temperature to have abeneficial effect, wherein Y is greater than X. In accordance with thepresent invention, the applied energy and heat sink of a femoralcomponent 192 are designed and configured for gender specific use,taking into account the reactive differences between the female and malegenders.

Similarly, a localized change in pH can have similar beneficial effects,which include (but are not limited to): aiding in the alleviation oflocalized pain, fighting of local infections, and increasing vascularflow and permeability of vessels at the treatment site to controldelivery of pharmaceutical agent. For example, a localized increase inpH may increase the permeability of the local tissue, thereby allowingfor an increased and more efficient absorption of the pharmaceuticalagent into the treatment site.

The energy sink 196 in the femoral component 192 can be a pH sink 196.The pH sink 196 can be incorporated into the femoral component 192 or bepositioned separate from the femoral component 192. Therefore, the pHsink 196 may be configured to release a chemical to produce either anincrease or decrease in the local pH in order to provide a moregender-specific use. An acidic agent would lower the pH and a basicagent would raise the pH. Such agents are well-known to those ofordinary skill.

The male and female genders react differently to localized changes inpH. For example, a localized increase or decrease in the acidity of thesurrounding tissue may have a beneficial effect on a female, but noeffect on a male. As a result of the different effects on the male andthe female genders, the chemical and release rate thereof is dependenton the gender of the patient. As such, in accordance with the presentinvention, the pH sink 196 is designed and configured for genderspecific use, taking into account the reactive differences between thefemale and male genders.

Additionally, temperature or pH changes may also be used to induce therelease of beneficial enzymes, proteins, hormones, etc. from the cellsin the treatment site. For example, a localized increase in acidityand/or temperature can be perceived as a physical damage or an infectionto the local area. In response, the local cells may release beneficialproteins, enzymes, hormones, etc.

There am several ways to define how a treatment or device may qualify asbeing gender specific. One way a treatment or device may be consideredgender specific is to identify differences in product design ortreatment between men and women. Another way to identify whether adevice or treatment is gender specific is to determine who the intendedpatients are. For instance, a product line having two or more modelswhere at least one model is marketed or designed more for men than womenand another model is marketed or designed more for women than men wouldbe gender-specific, and therefore within the scope of the invention. Ifthere are measurable differences between the product design or treatmentfor men versus women, then another way to identify a product ortreatment as gender-specific would be by having these differences meetor exceed a threshold amount. For example, in cases where two or moremodels are offered to account for gender differences at least one of thevarying design parameters will differ by about 5 percent or more, andmore preferably will differ by about 10 percent or more.

Thus, differences in a range of sizes of a device may in some cases beby 5 percent or more or by 10 percent or more. Likewise, othermeasurable differences, such as quantity, concentration, or releaserates of medications may differ by these numerical amounts. Of course,skilled artisans would readily appreciate that these differences may beapplied to any other measurable design parameter of a device ortreatment, including duration, amount, thickness, forces applied,diameter, width, height, volume, density, temperature, pH changes, orthe like.

Furthermore, while one exemplary embodiment of a medical implantdiscussed above refers to a prosthetic knee joint, it is contemplatedthat the medical implant can be any prosthetic implant for use in abody, including, ankle, knee, hip, spine, neck, wrist, elbow or shoulderimplants. Furthermore, the medical implant can be, but is not limitedto, tissue, scaffold, biological implants, graft, tissue graft, screws,plate, rods, or similar devices.

Pharmaceutical delivery of medication may also be provided in agender-specific manner. The release and absorption rates of drugs aredifferent for men and women. Oral medication, for instance, may beabsorbed differently due to resorption rates in the stomach, intestine,duodenum, abdomen, or the like. Likewise, intravenous medications canreact differently for men and women. The present invention contemplatesan improved drug delivery that accounts for gender-specific differences.One such example of an improved, gender-specific drug delivery system isin chemotherapy, which is known for being a thermal gradient drugdelivery. Since men and women have different temperatures, diurnalchanges, and pH, drug-delivery systems would benefit from accounting forone or more of these differences. For example, dosages and the route ofadministration (e.g. oral release or intravenous) may be varied for menand women. The initial dosage for men may differ from the initial dosagefor women, the amount of drugs used in subsequent doses may differ, andthe time period between subsequent doses also may differ between men andwomen. Thus, a medicine given to a man may involve a second dose 8 hourslater, while for women the second dose may be 6 hours later, or based ondiurnal curves of men and women.

As noted previously, one consequence of accounting for gender-specificdifference in medical treatment is that medical treatment may becomemore complicated or difficult. This additional complexity, however, canbe reduced by providing gender-specific indictors on the devices,packaging, or instructions.

The system includes gender specific packaging material whichdifferentiates use for male and female patients. The packaging materialcan include labeling or color coding to specify gender usage. Formedications, the packaging material can include labeling, inserts, orproduct information which provides dosage information for both male andfemale patients.

Referring now to FIG. 24, a product packaging material 200 of thepresent invention is shown. The packaging material 200 includes a label202 affixed thereto or, in the alternative, incorporated into thepackaging material 200. The label 202, illustrated in FIG. 25, providesinformation identifying the contents and usage of the packaging material200, which can include a gender specifier 204. The gender specifier 204identifies the gender that the contents of the packaging material 200are intended for. For example, the gender specifier 204 can be inpictorial, graphic, or text (or combination) form such as “FEMALE” or“MALE.” It is contemplated that the text form of the gender specifier204 can be provided in a variety of languages, depending of the intendedcountry of use.

Alternatively, the gender specifier 204 can be in the form of a colorcoding, wherein a first color is used to indicate a female gender and asecond color is used to indicate a male gender. The first and secondcolors may be selected from colors that are recognizable as genderindicators. For example, to indicate a female gender the first color canbe pink while blue may be used to indicate a male gender. However, it iscontemplated that first and second colors can be any colors which arereadably discernable as indicators of gender. The color coded genderspecifier 204 is depicted as incorporating only a portion of the label202. However, it is contemplated that the entire label 202 can be colorcoded to specify gender.

In a further embodiment, the gender specifier 204 can be a symbolic formfor representing female and male genders. For example, the genderspecifier 204 can be the western culture ideograms for female and malegenders, namely “♀” for the female gender and “♂” for the male gender.However, it is contemplated that gender symbols can be any symbols whichare readably discernable as indicators of gender.

The label 202 can include additional information, including, the productname 206 and product technical information 208. The product name 206 canbe a name used by the company for the product, used to identify theorigin of the product, such as CHARITE owned by DePuy Spine, Inc., foran artificial disc. Alternatively, the product name can be a generic ordescriptive name of the product, such as ARTIFICIAL DISC. Additionaltechnical information 208 can be provided, such as information relatingto the size, material, date of manufacture, lot or control number, etc.

In an alternative embodiment, the packaging material 200 is the genderspecifier. For example, the packaging material 200 can be color coded toindicate gender, wherein a first color is used to indicate a femalegender and a second color is used to indicate a male gender. The firstand second color are selected from colors that are recognizable a genderindicators. For example, to indicate a female gender the first color canbe the color pink and to indicate a male gender the second color can bethe color blue. However, it is contemplated that first and second colorscan be any colors which are readily discernable and indicators ofgender.

Referring to FIG. 26, an exemplary medicine container 210 is provided,wherein the medicine container 210 includes a label 212 affixed thereto.The label 212 provides information identifying the contents 214 andusage of the enclosed medicine. The usage information includes therecommend dosage for each gender, wherein gender specifiers 216 and 218annotate the gender dosage information 220 and 222. As described above,the gender specifiers 216 and 218 can be in a text form, such as“FEMALE” and “MALE.” Alternatively, the gender specifiers 216 and 218can be in the form of a color coding or in symbolic representations.

In an alternative embodiment, a product insert can be provided in themedicine container 210. Similar to the label 212, the product insert canprovide information identifying the contents and usage of the enclosedmedicine, which can include gender specifiers used in conjunction withdosage information.

Another technology that may be utilized to provide a gender-specificindicator is RFID chips. RFID chips may be associated with equipment,instruments, or in sterile packaging so that identification of theintended gender for the devices may be quickly determined. This may beof particular benefit where it is difficult to visually determine thegender-specific design. For example, it may be difficult to visuallyconfirm the intended gender of light sensitive therapeutics, internalcomponents, sealed materials, or implanted devices. Likewise,instrumentation kits may involve several tools or devices that would betime-consuming to confirm are all intended for the same gender. Byassociating an RFID tag with these devices, however, the gender-specificinformation can be quickly retrieved. In one embodiment, RFID chipsprovided in packaged gender-specific drugs are used to determineremaining quantities of medicine.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention.

What is claimed is:
 1. A gender-specific pharmaceutical product fordifferentiating use for a female or male, the product comprising: apackage containing a pharmaceutical comprising a central nervous systemagent, the pharmaceutical being present in a recommended female dosageor a recommended male dosage; and a label on the package or an insertpositioned in the package, wherein the label, the insert, or the packageincludes the recommended female dosage and a female-specific indicia ifthe pharmaceutical is present in the recommended female dosage or therecommended male dosage and a male-specific indicia if thepharmaceutical is present in the recommended male dosage, thefemale-specific indicia or the male-specific indicia on the label, theinsert or the package differentiating use of the product for the femaleor the male.
 2. The product of claim 1, wherein the recommended femaledosage is different than the recommended male dosage.
 3. The product ofclaim 2, wherein the recommended female dosage is different than therecommended male dosage based on differences between males and femalesin rates of drug absorption and/or metabolism.
 4. The product of claim2, wherein the recommended female dosage is different than therecommended male dosage based on differences between males and femalesin at least one of temperature, diurnal changes, pH changes, hormonalchanges, and susceptibility to diseases or medical conditions.
 5. Theproduct of claim 1, wherein the pharmaceutical is provided as at leastone of a tablet, capsule, powder or liquid.
 6. The product of claim 1,wherein the female-specific indicia or the male-specific indicia is inpictorial, graphic, color-coded, or text form.
 7. The product of claim1, wherein the pharmaceutical is colored with the same color as thefemale-specific indicia if the pharmaceutical is present in therecommended female dosage or as the male-specific indicia if thepharmaceutical is present in the recommended male dosage.
 8. The productof claim 1, further comprising an RFID tag associated with the package.9. The product of claim 1, wherein the label, the insert or the packageprovides a recommended time period between administration of therecommended female dosage if the pharmaceutical is present in therecommended female dosage, or the recommended male dosage if thepharmaceutical is present in the recommended male dosage.
 10. Theproduct of claim 1, wherein the recommended time period is different ifthe pharmaceutical is present in the recommended female dosage then therecommended time period if the pharmaceutical is present in therecommended male dosage.
 11. The product of claim 1, wherein the centralnervous system agent is a central nervous system depressant.
 12. Theproduct of claim 1, wherein the central nervous system depressant is asedative.
 13. A patient group-specific pharmaceutical product fordifferentiating use for a first patient group or a second patient group,the product comprising: a package containing a pharmaceutical comprisinga central nervous system agent, the pharmaceutical being present in arecommended first patient group dosage or a recommended second patientgroup dosage; and a label on the package or an insert positioned in thepackage, wherein the label, the insert, or the package includes therecommended first patient group dosage and a first patientgroup-specific indicia if the pharmaceutical is present in therecommended first patient group dosage or the recommended second patientgroup dosage and a second patient group-specific indicia if thepharmaceutical is present in the recommended second patient groupdosage, the first patient group-specific indicia or the second patientgroup-specific indicia on the label, the insert or the packagedifferentiating use of the product for the first patient group or thesecond patient group.
 14. The product of claim 13, wherein therecommended first patient group dosage is different than the recommendedsecond patient group dosage.
 15. The product of claim 14, wherein therecommended first patient group dosage is different than the recommendedsecond patient group dosage based on differences between the firstpatient group and the second patient group in rates of drug absorptionand/or metabolism.
 16. The product of claim 14, wherein the recommendedfirst patient group dosage is different than the recommended secondpatient group dosage based on differences between the first patientgroup and the second patient group in at least one of temperature,diurnal changes, pH changes, hormonal changes, and susceptibility todiseases or medical conditions.
 17. The product of claim 13, wherein thepharmaceutical is provided as at least one of a tablet, capsule, powderor liquid.
 18. The product of claim 13, wherein the first patientgroup-specific indicia or the second patient group-specific indicia isin pictorial, graphic, color-coded, or text form.
 19. The product ofclaim 13, wherein the pharmaceutical is colored with the same color asthe first patient group-specific indicia if the pharmaceutical ispresent in the recommended first patient group dosage or as the secondpatient group-specific indicia if the pharmaceutical is present in therecommended second patient group dosage.
 20. The product of claim 13,further comprising an RFID tag associated with the package.
 21. Theproduct of claim 13, wherein the label, the insert or the packageprovides a recommended time period between administration of therecommended first patient group dosage if the pharmaceutical is presentin the recommended first patient group dosage, or the recommended secondpatient group dosage if the pharmaceutical is present in the recommendedsecond patient group dosage.
 22. The product of claim 13, wherein therecommended time period is different if the pharmaceutical is present inthe recommended first patient group dosage then the recommended timeperiod if the pharmaceutical is present in the recommended secondpatient group dosage.
 23. The product of claim 13, wherein therecommended first patient group dosage is different from the recommendedsecond patient group dosage by 10 percent or more.
 24. The product ofclaim 13, wherein the recommended first patient group dosage or therecommended second patient group dosage includes an initial dosage. 25.The product of claim 13, wherein the central nervous system agent is acentral nervous system depressant.
 26. The product of claim 13, whereinthe central nervous system depressant is a sedative.
 27. A method ofpackaging the gender-specific pharmaceutical product of claim 1 fordifferentiating use of the product for a female or a male, the methodcomprising: preparing the package, the label, or the insert to includethe female-specific indicia or the male-specific indicia on the package,the label, or the insert to differentiate use of the product for thefemale or the male.
 28. A method of packaging the gender-specificpharmaceutical product of claim 13 for differentiating use of theproduct for a first patient group or a second patient group, the methodcomprising: preparing the package, the label, or the insert to includethe first patient group-specific indicia or the second patientgroup-specific indicia on the package, the label, or the insert todifferentiate use of the product for the first patient group or thesecond patient group.